2.2M At-Home COVID-19 Tests Recalled Due to False Positives in FDA’s ‘Most Serious’ Recall Level

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Ellume At-Home COVID-19 Test Recall Overview

• Who: The US Food and Drug Administration (FDA) is recalling more than 2.2 million Ellume COVID-19 tests.
• Why: Some batches of the Ellume-brand tests have a higher than acceptable rate of false positive results, putting lives in danger, the FDA says.
• Where: Ellume at-home COVID-19 tests have been recalled across the United States.

More than 2.2 million at-home COVID-19 tests made by Australian company Ellume are being recalled by the U.S. Food and Drug Administration (FDA) in a Class 1 recall—the agency’s most serious type of recall.

The FDA issued the recall notice on its website on Nov. 11 for 2,212,335 lots of Ellume COVID-19 Home Test manufactured between Feb. 24 and Aug. 11, 2021.

The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits

The tests are being recalled because they have higher-than-acceptable false positive test results for COVID-19, the recall says. The reliability of negative tests is not affected.

However, the false positives can be life-threatening, too, the FDA says.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.”

Home COVID-19 Test False Positive May Delay Diagnosis, Other Risks 

If a test shows the person has the virus when they do not, it could delay diagnosing the actual cause of the person’s illness, which could be another life-threatening disease, the FDA warns.

It could expose people who do not have COVID-19 to the virus if they are quarantined with others who do have it. And treatments for COVID-19, administered to someone who doesn’t actually have the virus, could result in adverse side effects.

Meanwhile, those who believe they have already had the virus might delay their vaccine, which could lead to further spread of COVID-19. Some consumers who got a false positive result from the test may also have missed work or school due to the issue.

The FDA said the company first advised it about the faulty tests in October. So far, 35 false positives from these tests have been reported to the FDA. No deaths have been reported.

The over-the-counter nasal swab tests can be purchased at a pharmacy or grocery store and taken at home. Shops selling the tests have been advised to “remove affected products from shelves and stop sales,” quarantine the products immediately and reach out to an Ellume sales rep for the next steps.

Consumers who have Ellume tests should check if their product is from an affected lot here. If it is, and they have got a positive result from the test in the past two weeks, they should contact their health professional to get another COVID-19 test to confirm the positive test result.

As the coronavirus continues to spread, consumers are seeking legal help in its wake. Click here for our germ-free guide to the coronavirus outbreak, updated continually with the latest in legal news. 

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